In the world of parenteral pharmaceutical products, Ceftriaxone Sodium and Sulbactam Sodium for Injection stands out as a powerful combination used to combat a wide range of bacterial infections. This sterile injectable formulation combines the third-generation cephalosporin ceftriaxone with the beta-lactamase inhibitor sulbactam, increasing its efficacy against resistant organisms.
Manufacturing this formulation requires precision, regulatory compliance, a sterile environment, and a highly experienced technical team. As a company deeply involved in dry powder injectable manufacturing, we bring a wealth of experience, expertise, and confidence in producing Ceftriaxone-Sulbactam Injection with the highest standards of safety and efficacy.
With decades of pharmaceutical manufacturing experience, we at R K Lifecare Inc. have developed a firm grasp on aseptic techniques, sterile formulation development and Good Manufacturing Practices (GMP). Our practical experience in handling beta-lactam antibiotics, including third-generation cephalosporins such as ceftriaxone, is evident in our production results, market acceptance and regulatory compliance.
Given the allergenic and potent nature of cephalosporins, producing dry injections of ceftriaxone and sulbactam requires strict containment strategies. Our facility design includes:
Dedicated beta-lactam blocks
Class 100 (ISO 5) cleanroom environments for filling
Validated air handling units (AHUs) with HEPA filters
Dedicated HVAC systems
Airlocks and pressure differentials
These ensure that cross-contamination risks are eliminated and product sterility is maintained at every stage.
Ceftriaxone Sodium (USP/IP/BP grade): A bactericidal agent with broad-spectrum activity.
Sulbactam Sodium (USP/IP/BP grade): A beta-lactamase inhibitor that extends Ceftriaxone’s spectrum against resistant strains.
Our R&D and QA teams ensure both APIs:
Meet pharmacopeial specifications
Have low residual solvents
Show desired microbiological purity
Exhibit correct particle size distribution for proper blending
The commonly used clinical formulation is:
Ceftriaxone Sodium: 1000 mg
Sulbactam Sodium: 500 mg
OR
Ceftriaxone Sodium: 500 mg
Sulbactam Sodium: 250 mg
This 2:1 ratio is critical to preserve the synergy between both agents. Our formulation chemists perform:
Compatibility studies
Moisture content analysis
Stability studies under ICH guidelines
Pre-formulation trials for powder behavior, flow properties, and sterility retention
All raw materials are sourced from GMP-certified vendors and tested as per pharmacopeial standards. Key tests include:
Identification (IR/UV)
Assay (HPLC/UV)
Water content (Karl Fischer)
Sterility
Microbial limits
Heavy metals
All raw materials receive approval from Quality Control (QC) before being released to production.
Carried out in a Class 100,000 (ISO 8) area
Operators wear sterile gowning
Ingredients are weighed using calibrated balances
Dispensing is performed in reverse laminar airflow (RLAF) booths to minimize contamination
After weighing:
APIs are transferred to a Rapid Mixer Granulator (RMG) or double cone blender
Mixing duration and speed are validated
Blend uniformity is tested using content uniformity assays
In-process control (IPC) is performed to check for segregation, particle agglomeration, and flowability
For lyophilized injections, dry powder filling is standard. However, some formulations require:
Solution preparation in Water for Injection (WFI)
pH adjustment
Sterile filtration using 0.22-micron filters
Transfer to sterile filling area
This step must be conducted in Class 100 (ISO 5) zones under strict aseptic conditions.
Vials are washed using 5-stage vial washing machines using:
Purified Water (PW)
WFI
Compressed air
Drying with laminar airflow
Post-washing, vials are depyrogenated in hot-air tunnels at 320°C.
In our sterile fill area:
Mixed powder is filled using automatic sterile powder filling machines
Nitrogen purging is applied before and after filling
Fill weight consistency is checked every 15-30 minutes
Class 100 environment is strictly maintained with restricted operator movement
Sterile rubber stoppers are placed immediately after filling
Aluminum seals are crimped onto the vials using automated sealing machines
Visual inspection is performed under white and black light backgrounds to identify particulate matter, cracks, or foreign particles
In case of lyophilized formulation:
Vials are pre-frozen at -40°C
Transferred to a lyophilizer for sublimation under vacuum
Final moisture content is targeted to be <1%
The dried cake should appear uniform, white/off-white, and porous
Post-lyophilization, vials are sealed under vacuum or nitrogen.
Blend uniformity
Weight variation
Environmental monitoring
Sterility assurance
Each batch undergoes:
| Test | Method |
|---|---|
| Appearance | Visual |
| pH | Potentiometry |
| Reconstitution Time | Manual test |
| Water Content | Karl Fischer |
| Assay | HPLC |
| Related Substances | HPLC |
| Sterility | Membrane Filtration |
| Endotoxins | LAL Test |
| Particulate Matter | Visual + Light Obscuration |
| Uniformity of Content | Spectrophotometry / HPLC |
Only batches meeting all QC parameters are released for packaging.
Packaging is done using:
Glass vials (USP Type I)
Sterile rubber stoppers
Aluminum flip-off caps
Final labeling is done in compliance with DGCI, WHO, and global regulatory standards. Labels include:
Brand name
Composition
Batch No.
Manufacturing and Expiry Dates
Storage Conditions
Reconstitution Instructions
Store at <25°C, away from light and moisture
Shelf life: 24 to 36 months, depending on stability data
Reconstituted solution (in sterile water/lidocaine) should be used within 6 hours at room temperature or 24 hours if refrigerated.
We follow:
WHO-GMP
PIC/S
Schedule M
US FDA, EU GMP guidelines for future market expansions
Each batch is documented through:
Batch Manufacturing Records (BMR)
Batch Packaging Records (BPR)
Certificate of Analysis (COA)
Certificate of Compliance (COC)
As a responsible dry injection manufacturer, we implement:
Effluent Treatment Plants (ETP)
Solvent recovery units
HEPA exhaust systems
Worker PPEs, training modules, and biosafety drills
Handling cephalosporins demands a closed-loop system to avoid occupational exposure, and our operations reflect this care.
Our client-centric approach, transparent documentation, and zero-defect policy have earned us long-standing trust with:
Government tenders
Private hospitals
Exporters and distributors
We constantly upgrade our systems through:
Six Sigma methods
LEAN manufacturing
Regulatory audits and certifications
Our repeat clientele and regulatory inspections passed without major observations demonstrate our commitment to quality.